• Establish your quality management system.

  • Address external QMS requirements.

• Document your quality management system.

• Implement your quality management system.

• Maintain your quality management system.

• Improve your quality management system.

4.2.1 MANAGE QUALITY MANAGEMENT SYSTEM DOCUMENTS

• Develop documents for your organization's QMS.

• Ensure that your organization's personnel are familiar with its QMS documentation.                   

• Make sure that your organization's QMS documents
  respect and reflect what you do and how you do it.

4.2.2 PREPARE QUALITY MANAGEMENT SYSTEM MANUAL

• Establish a quality manual for your organization.

• Maintain your organization's quality manual.

4.2.3 CONTROL QUALITY MANAGEMENT SYSTEM DOCUMENTS

• Control your organization's QMS documents.

• Control documents that are used as QMS records.

4.2.4 ESTABLISH QUALITY MANAGEMENT SYSTEM RECORDS

• Establish your organization's QMS records.

• Establish a procedure to control your QMS records.

  • Define how your suppliers control records.

• Support the development of your organization's QMS.

• Support the implementation of your organization's QMS.

• Support efforts to continually improve the effectiveness of your organization's QMS.            

• Enhance customer satisfaction by ensuring that customer requirements are being identified.

• Enhance customer satisfaction by ensuring that customer requirements are being met.

  • Ensure that product conformity is measured.

  • Ensure that on-time delivery performance is measured.

• Ensure that your organization's quality policy serves its overall purpose.                 

• Ensure that your quality policy makes it clear that requirements must be met.             

• Ensure that your quality policy makes a commitment to continually improve the effectiveness of your QMS.

• Ensure that your quality policy supports your organization's quality objectives               

• Ensure that your quality policy is communicated and discussed throughout your organization.

• Ensure that your quality policy is periodically
  reviewed to make sure that it is still suitable.

5.4.1 ESTABLISH QUALITY OBJECTIVES

• Support the establishment of quality objectives.

• Establish quality objectives for your organization.

• Make sure that your quality objectives are effective.

5.4.2 PLAN QUALITY MANAGEMENT SYSTEM (QMS)

• Plan the establishment of your QMS.

• Plan the documentation of your QMS.

• Plan the implementation of your QMS.

• Plan the maintenance of your QMS.

• Plan the continual improvement of your QMS.

5.5.1 DEFINE RESPONSIBILITIES AND AUTHORITIES

• Ensure that QMS responsibilities and authorities are defined.

• Ensure that QMS responsibilities and authorities are communicated throughout your organization.

5.5.2 CREATE MANAGEMENT REPRESENTATIVE ROLE

• Appoint a member of your organization's management to oversee your QMS.                  

• Give your management representative authority over and responsibility for your organization's QMS.

• Make sure that your management representative has the organizational freedom to resolve quality management issues.

5.5.3 SUPPORT INTERNAL COMMUNICATION

• Ensure that appropriate communication processes are established within your organization.

• Ensure that internal communication occurs throughout your organization.                   

5.6.1 REVIEW QUALITY MANAGEMENT SYSTEM (QMS)

• Carry out management reviews of your QMS at planned intervals.                  

• Evaluate improvement opportunities.

• Assess the need to make changes.

• Maintain a record of your management reviews.

5.6.2 EXAMINE MANAGEMENT REVIEW INPUTS

• Examine information about your QMS (inputs).

5.6.3 GENERATE MANAGEMENT REVIEW OUTPUTS

• Generate management review decisions and actions to improve your organization.             

• Generate management review decisions and actions to change your general quality orientation.                       

• Generate management review decisions and actions to address resource needs.              

• Identify the resources that your QMS needs.

• Provide the resources that your QMS needs.

6.2.1 ENSURE THE COMPETENCE OF WORKERS

• Ensure the competence of anyone within your  MS who could directly or indirectly affect your ability to meet product requirements.                        

6.2.2 MEET COMPETENCE REQUIREMENTS

• Identify the competence requirements of personnel within your QMS who perform work that could directly or indirectly affect your organization's ability to meet product requirements.                                                     

• Provide training, or take other suitable steps, to meet your organization's QMS competence requirements.

• Evaluate the effectiveness of your organization's QMS training and awareness activities.

• Maintain suitable records which show that personnel within your QMS are competent.

• Identify the infrastructure that your organization needs in order to ensure that product requirements are met.

• Provide the infrastructure that your organization needs in order to ensure that product requirements are met.

• Maintain the infrastructure that your organization needs in order to ensure that product requirements are met.

• Identify the work environment that your organization needs in order to ensure that product requirements are met.

• Manage the work environment that your organization needs in order to ensure that product requirements are met.

• Establish a product realization planning process.

• Use your product realization planning process to plan the realization of your organization's products.

  • Set product quality objectives.

    • Set product safety objectives.

    • Set product reliability objectives.

    • Set product availability objectives.

    • Set product maintainability objectives.

    • Set product suitability objectives.

    • Set product disposal objectives.

  • Specify product quality requirements.

    • Specify product safety requirements.

    • Specify product reliability requirements.

    • Specify product availability requirements.

    • Specify product maintainability requirements.

    • Specify product suitability requirements.

    • Specify product disposal requirements.

• Prepare planning outputs that are suitable and consistent with your organization's methods.

• Develop the processes that you will need to use in order to realize products.                        

7.1.1 ESTABLISH A PROJECT MANAGEMENT PROCESS

• Plan your product realization projects.

• Manage your product realization projects.

7.1.2 ESTABLISH A RISK MANAGEMENT PROCESS

• Establish a process to manage the risk associated with the achievement of your product realization requirements.

• Implement your risk management process.

• Maintain your risk management process.

7.1.3 ESTABLISH A CONFIGURATION MANAGEMENT PROCESS

• Establish a configuration management process that is appropriate to the products your organization realizes.

• Implement your configuration management process.

• Maintain your configuration management process.

7.1.4 ESTABLISH A WORK TRANSFER CONTROL PROCESS

• Establish a process to control the transfer of work.

• Implement your work transfer control process.

• Maintain your work transfer control process.

7.2.1 IDENTIFY YOUR UNIQUE PRODUCT REQUIREMENTS

• Identify the requirements that your customers want you to comply with.                         

• Identify the requirements that are dictated by your product's intended use or purpose.

• Identify the requirements that are imposed
  on your products by external agencies.            

• Identify any additional requirements that are important to your organization and must be met.

• Identify the special requirements that your customers want you to comply with.                       

• Identify the special requirements that are dictated by your product's intended use or purpose.

• Identify the special requirements that are imposed on your products by external agencies.

7.2.2 REVIEW CUSTOMERS' PRODUCT REQUIREMENTS

• Review your customers' product requirements.

• Maintain a record of your product requirement reviews.

• Control changes in customers' product requirements.

7.2.3 COMMUNICATE WITH YOUR CUSTOMERS

• Establish customer communication arrangements.

• Implement customer communication arrangements.

7.3.1 PLAN PRODUCT DESIGN AND DEVELOPMENT

• Plan the design and development of your products.

• Control the design and development of your products.

• Update your planning outputs whenever product design and development progress makes this necessary.

7.3.2 IDENTIFY DESIGN AND DEVELOPMENT INPUTS

• Define product design and development inputs.

• Maintain a record of design and development inputs.

• Review your product design and development inputs.

7.3.3 GENERATE DESIGN AND DEVELOPMENT OUTPUTS

• Produce product design and development outputs.

• Approve product design and development outputs before they are formally released.

• Verify that product design and development outputs meet design and development input requirements.

7.3.4 CARRY OUT DESIGN AND DEVELOPMENT REVIEWS

• Perform systematic design and development reviews throughout the design and development process.

• Maintain a record of design and development reviews.

7.3.5 PERFORM DESIGN AND DEVELOPMENT VERIFICATIONS

• Carry out design and development verifications.

• Maintain a record of design and development verifications.

7.3.6 CONDUCT DESIGN AND DEVELOPMENT VALIDATIONS

7.3.6.1 MANAGE DESIGN AND DEVELOPMENT VERIFICATION AND VALIDATION TESTING

7.3.6.2 DOCUMENT DESIGN AND DEVELOPMENT VERIFICATIONS AND VALIDATIONS

7.3.7 MANAGE DESIGN AND DEVELOPMENT CHANGES

• Identify changes in design and development.

• Control changes in design and development.

• Record changes in design and development.

• Review changes in design and development.

• Verify changes in design and development.

• Validate changes in design and development.

• Approve changes in design and development before you implement these changes.

7.4.1 ESTABLISH CONTROL OF YOUR PURCHASING PROCESS

• Establish criteria that you can use to control suppliers.

• Establish a decision making process to decide what approval status suppliers should have.

• Evaluate your suppliers' ability to supply products that meet your organization's requirements.

• Select suppliers that are capable of supplying products that meet your organization's specified requirements.

• Make sure that purchased products meet specified purchase requirements.

• Use customer-approved special process sources whenever this is a requirement.                   

• Periodically review supplier performance.

• Make sure that your organization accepts responsibility for all purchased products.                          

7.4.2 SPECIFY YOUR PURCHASING REQUIREMENTS

• Describe your purchasing requirements.

• Ensure that purchasing requirements are adequately specified before you discuss them with suppliers.

7.4.3 VERIFY YOUR PURCHASED PRODUCTS

• Establish product verification or inspection methods in order to ensure that purchased products meet purchase requirements.

• Implement product verification or inspection methods in order to ensure that purchased products meet purchase requirements.

• Verify your organization's purchased products.

• Delegate verification activities to your supplier or use supplier certifications to show that purchased products meet requirements.

• Identify and record purchased products that are released for production use whenever verification activities have not yet been completed.                                              

7.5.1 ESTABLISH CONTROL OF PRODUCTION AND SERVICE

7.5.1.1 VERIFY THAT PRODUCTION PROCESS MEETS REQUIREMENTS

7.5.1.2 CONTROL CHANGES IN YOUR PRODUCTION PROCESS

7.5.1.3 CONTROL EQUIPMENT, TOOLS, AND SOFTWARE PROGRAMS

7.5.1.4 PROVIDE POST-DELIVERY SUPPORT

7.5.2 VALIDATE PRODUCTION AND SERVICE PROVISION

• Validate production and service provision processes         whenever process outputs cannot be measured, monitored,         or verified until after the product is in use or the service      has been delivered (such a process is often referred         to as a special process).                             

• Establish arrangements to control special processes.

7.5.3 IDENTIFY AND TRACK YOUR PRODUCTS

• Establish the identity of your products

• Identify the monitoring and measurement status of your organization's products.

7.5.4 PROTECT PROPERTY SUPPLIED BY CUSTOMERS

• Identify property supplied to you by customers.

• Verify property supplied to you by customers.

• Protect property supplied to you by customers.

• Safeguard property supplied to you by customers.

7.5.5 PRESERVE YOUR PRODUCTS AND COMPONENTS

• Make sure that your products and components continue to conform to requirements while they are being processed internally.                         

• Make sure that your products and components continue to conform to requirements while they are being delivered to the intended destination.                

• Make sure that your product preservation process is carried out in accordance with all relevant specifications and requirements.                                 

• Preserve your products and components.

• Identify your organization's monitoring and measuring needs and requirements.                 

• Select equipment that can meet your organization's monitoring and measuring needs and requirements.

• Use monitoring and measuring equipment to demonstrate that products meet requirements.

• Maintain a register of your organization's monitoring and measuring equipment.                  

• Define the process that is used to calibrate or verify your monitoring and measuring equipment.

• Establish monitoring and measuring processes.

• Calibrate your monitoring and measuring equipment whenever necessary to ensure that results are valid.

• Protect your monitoring and measuring equipment.

• Confirm that monitoring and measuring software is capable of doing the job you want it to do.

• Evaluate the validity of previous measurements whenever you discover that your measuring or monitoring equipment is out of-calibration.

• Identify the monitoring, measurement, and analytical processes that your organization needs to have in order to be able to demonstrate conformity and make improvements.                                            

• Plan how monitoring, measurement, and analytical processes will be used to demonstrate conformity and make improvements.                                         

• Implement your organization's monitoring, measurement, and analytical processes.                 

8.2.1 MONITOR AND MEASURE CUSTOMER SATISFACTION

• Establish methods that you can use to monitor and measure customer satisfaction (perceptions).

• Monitor and measure customer satisfaction.

8.2.2 PLAN AND PERFORM REGULAR INTERNAL AUDITS

• Establish an internal audit procedure.

• Carry out internal audits of your QMS.

• Take action to address audit results.

8.2.3 MONITOR AND MEASURE YOUR QMS PROCESSES

• Select suitable methods to monitor and measure the processes that make up your organization's QMS.

• Monitor and measure your QMS processes.

• Take appropriate action whenever your QMS processes fail to achieve planned results.

8.2.4 MONITOR AND MEASURE PRODUCT CHARACTERISTICS

• Monitor your organization's product characteristics.

• Measure your organization's product characteristics.

• Establish a nonconforming products procedure.

• Document your nonconforming products procedure.

• Implement your nonconforming products procedure.

• Maintain your nonconforming products procedure.

• Figure out what kind of data you need to collect about your organization's QMS.                  

• Collect data about your organization's QMS.

• Provide information by analyzing your QMS data.

8.5.1 IMPROVE THE EFFECTIVENESS OF YOUR QMS

• Identify continual QMS improvement opportunities.

• Continually improve the effectiveness of your QMS.

• Use information to improve the effectiveness of your QMS.

• Monitor the implementation of your QMS improvement activities.

• Evaluate the effectiveness of your QMS improvement activities.

8.5.2 CORRECT NONCONFORMITIES TO PREVENT RECURRENCE

• Establish a corrective action procedure.

• Document your corrective action procedure.

• Implement your corrective action procedure.

• Maintain your corrective action procedure.

8.5.3 PREVENT THE OCCURRENCE OF NONCONFORMITIES

• Establish a preventive action procedure.

• Document your preventive action procedure.

• Implement your preventive action procedure.

• Maintain your preventive action procedure.

Introduction to AS9100 Standard

Overview of AS9100 Quality Standard

Plain English Aerospace QMS Definitions

How to Upgrade to the new QMS Standard

AS9100C (2009) QMS Gap Analysis Tool

AS9100C (2009) Internal Audit Program

Our Plain English Approach

RELATED RESOURCES

Quality Management Standards

ISO 9001 Quality Management Library

ISO 31000 2009 Risk Management Library

ISO 9004 2009 Quality Management Library

ISO IEC 20000-1 Service Management Library

Knowledge and Skills QMS Auditors Should Have